510(k) · Cleared
ClearedDynamometer - Model Fce and Model MSC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ametek · LBB Dynamometer, Ac-Powered
Cleared on Nov 16, 2004 after a 28-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Nov 16, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- LBB
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK042889 Dynamometer - Model Fce and Model MSCAmetek · 2004
- Descendant · cites it directly · 0 of its ownK162412 Hoggan Scientific® microFET2™Hoggan Scientific, LLC · 2017
- Descendant · cites it directly · 0 of its ownK052309 Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model…Saehan Corp. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042889 | Dynamometer - Model Fce and Model MSC | Ametek | 2004 | — |
| +1 | K162412 | Hoggan Scientific® microFET2™ | Hoggan Scientific, LLC | 2017 | — |
| +1 | K052309 | Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model SH5006 | Saehan Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | CSD200 - 500 LBF Capacity Named without a submission number | |
| * | — | CSD300 - 500 LBF Capacity Named without a submission number | |
| * | — | OS0500 -- 500 LBF Capacity Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K162412 (Hoggan Scientific, LLC, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LBB devicesLBB Dynamometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBB
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LBB
Too few LBB 510(k)s in any year since 2007 to give a median.
Recalls per year · LBB
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBB
No MAUDE report names LBB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Chatillon FCE and MSC series dynamometers is for performing manual muscle testing to measure muscle strength. The target population for this product is individuals recovering from physical injury or for sports medicine applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042889: Dynamometer - Model Fce and Model MSC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042889
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026